Description
Let’s do this. Let’s change the world.
In this vital role, you will work as part of a Product Team focusing on the **Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform** , accelerating Amgen’s product development and commercial manufacturing. You will collaborate with a dynamic, globally distributed team of technical product owners, business analysts, **test/validation engineers** , project managers, and scrum masters on the **design, development, validation, support, and continuous optimization** of Amgen Operations’ ELN ecosystem. This role requires **strong hands-on experience with enterprise platform and application testing in a GxP-regulated environment** , including **CSV/CSA activities** , to ensure systems meet regulatory, quality, and data integrity standards. In addition, the role demands **significant experience in Application Support and Maintenance (AMS)** , including incident management, release support, upgrades, patches, and operational stability of mission-critical laboratory platforms. The ideal candidate brings deep expertise in **ELN applications, enterprise application integration, end-to-end data and process harmonization** , and the seamless integration of laboratory instrument data with enterprise systems (e.g., LIMS, CDS, MES, data platforms). Success in this role requires comfort working in a **matrixed, global organization** , balancing innovation with compliance, operational excellence, and system reliability.
**Software Engineering & Platform Ownership**
+ Possess strong software development skills and rapidly translate concepts into working, production-ready solutions
+ Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards
+ Create and maintain documentation for **architecture, design, validation, deployment, disaster recovery, and operations**
+ Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms
+ Stay current with emerging technologies, industry best practices, and regulated system development trends
**GxP Testing, Validation & Quality**
+ **Lead and contribute to enterprise application testing in GxP environments** , ensuring compliance with FDA, EMA, and global regulatory requirements
+ Own and execute **CSV/CSA activities** , including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentation
+ Develop and maintain **test plans, test scenarios, and test scripts** for system enhancements, patches, upgrades, and vendor releases
+ Perform **functional, regression, integration, and user acceptance testing (UAT)** to ensure changes do not negatively impact validated functionality
+ Partner with Quality, Validation, and Business teams to support audits, inspections, and validation lifecycle activities
**Application Support & Maintenance (AMS)**
+ Provide **Level 2 / Level 3 application support** for ELN and associated enterprise platforms
+ Manage **incident, problem, and change processes** , including P1/P2 incident response and root cause analysis
+ Support **production releases, vendor upgrades, hotfixes, and patches** , ensuring minimal disruption to business operations
+ Work within **ITIL-based processes** using ServiceNow for incident, change, and problem management
+ Collaborate with infrastructure, vendor, and business partners to resolve operational bottlenecks and systemic issues
+ Ensure platform stability, performance monitoring, and operational readiness in regulated environments
**Cross-Functional Collaboration & Delivery**
+ Work closely with product teams, business partners, validation, quality, data scientists, and vendors
+ Drive system enhancements, bug fixes, and continuous improvements across the platform landscape
+ Develop and implement business process improvements to increase efficiency and effectiveness
+ Effectively operate within large, diverse, and globally dispersed teams in a matrixed organization
+ Leverage **AI and automation** to streamline testing, support workflows, and operational processes
**Basic Qualifications**
+ Bachelor’s OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering
**Functional Skills**
**Must-Have Skills**
+ Strong experience with **enterprise application testing in GxP-regulated environments**
+ Hands-on experience with **CSV/CSA validation methodologies and documentation**
+ Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing
+ Experience supporting **enterprise platforms with issue ticketing and customer-facing support models**
+ Proven experience in **Application Support & Maintenance (AMS)** for regulated systems
+ Experience with cloud platforms (AWS, Azure, GCP)
+ Incident response experience, including **P1/P2 production incidents**
+ Experience with **ServiceNow, ITIL processes, and change management workflows**
+ Ability to translate vendor capabilities and constraints into business-aligned solutions
+ Scripting and automation for server and operational task automation
+ Familiarity with AI tools (ChatGPT, Copilot, etc.) to improve productivity and workflows
**Good-to-Have Skills**
+ Strong customer focus with the ability to partner closely with business stakeholders
+ Experience supporting **200+ servers** or large-scale enterprise platforms
+ Experience with Smartsheets, Excel, Tableau, Spotfire
+ Ability to work independently with strong analytical and written communication skills
**Professional Certifications**
+ SAFe for Teams certification (preferred)
**Soft Skills**
+ Strong leadership, transformation, and change management capabilities
+ Ability to work effectively with global, virtual teams
+ Excellent analytical, troubleshooting, and decision-making skills
+ Ability to manage multiple priorities in a fast-paced, regulated environment
+ Strong presentation, communication, and stakeholder engagement skills
+ High degree of initiative, accountability, and self-motivation
